The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
Early identification of children at risk for neurodevelopment disorders is critical for prompt diagnosis and therapeutic interventions. Autism alone develops in 1 in 110 children in U). With more than 25 million 0-5 years old children in US (2011 data), the number of affected children is staggering. Substantial clinical evidence, primarily with children with autism, have proven that early intervention leads to improved functioning including language development, cognitive, social and behavioral remediation. Such improved outcome helps to reduce or eliminate the medical, educational and other special services needed by those affected children throughout their lifetime, which can save “society of $30,000 to $100,000 per child” (Pinto-Martin et al. 2005. Am J Public Health 95:1928). Therefore it has been recognized by all major professional and government agencies (NIH, CDC, AAP, Autism Speaks, etc.) that “early identification of developmental disorders is critical to the well□being of children and their families” (American Academy of Pediatrics (AAP) Committee on Children with Disabilities 2006).
Current tools for neurodevelopmental screening are typically based on parent reporting, clinical history and observation by specially trained professionals. AAP recommends that all children be screened by their primary care physician at 18 and 24 months using short screening tools such as the PEDS (Parents' Evaluation of Developmental Status) and the MCHAT (Modified Checklist for Autism in Toddlers). Unfortunately, the practice has not been widely adopted; no single tool picks up all children with neurodevelopmental disabilities. As with any human based methods, the accuracy and reliability of such methods are also directly affected by the performer's personal training and experience. In addition, behavioral symptoms usually lag behind the underlying neurophysiological changes. In fact, many children with neurodevelopmental disorders are not detected (AAP Committee on Children with Disabilities 2001, 2006).
Therefore there is a clinical need for an objective measure that can accurately track normal neurodevelopmental progress in infants and toddlers. Such biological (or physical) measures are more precise than behavioral exams and allow early identification of aberrant neurologic development even before behavioral symptoms appear. It is desirable that such tools be easy to use without the need of specially trained operators and be implementable in pediatricians' and family physicians' offices for quick screening of potential risk during the child's preventive visit.
Pupillary Light Reflex (PLR) testing has the potential to meet the clinical need of economic and objective measure to early identification of neurodevelopmental disorder in children. However, it is challenge to use currently available PLR devices (e.g., desktop, handheld or head□mount devices) in young children because such known devices are placed in close proximity of the eye, which causes unavoidable distractions, especially for infants or children with neurodevelopmental disorders who have heightened sensitivities and limited language. Such distractions often cause the child to close eyes or move the head away in reaction, and can lead to accommodation related pupil size changes (“near response”).